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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01844505




Registration number
NCT01844505
Ethics application status
Date submitted
29/04/2013
Date registered
1/05/2013
Date last updated
10/01/2024

Titles & IDs
Public title
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
Scientific title
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
2012-005371-13
Secondary ID [2] 0 0
CA209-067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable or Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Other interventions - Placebo for Nivolumab
Other interventions - Placebo for Ipilimumab

Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab - Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab - Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Experimental: Arm C: Ipilimumab+Placebo for Nivolumab - Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)


Other interventions: Nivolumab


Other interventions: Ipilimumab


Other interventions: Placebo for Nivolumab


Other interventions: Placebo for Ipilimumab
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to date of death (Assessed up to September 2016, approximately 39 months)
Primary outcome [3] 0 0
Rate of Overall Survival
Timepoint [3] 0 0
6, 12, and 24 months
Primary outcome [4] 0 0
Rate of Progression-Free Survival
Timepoint [4] 0 0
6, 12, and 24 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to date of death (Assessed up to September 2016, approximately 39 months)
Secondary outcome [3] 0 0
Objective Response Rate (ORR) Per Investigator Assessment
Timepoint [3] 0 0
From randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (Assessed up to February 2015, approximately 20 months)
Secondary outcome [4] 0 0
Progression-Free Survival Based on PD-L1 Expression Level
Timepoint [4] 0 0
From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)
Secondary outcome [5] 0 0
Overall Survival Based on PD-L1 Expression Level
Timepoint [5] 0 0
From randomization until date of death (Assessed up to September 2016, approximately 39 months)
Secondary outcome [6] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Timepoint [6] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation
Secondary outcome [7] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning
Timepoint [7] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation
Secondary outcome [8] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning
Timepoint [8] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation
Secondary outcome [9] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning
Timepoint [9] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation
Secondary outcome [10] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning
Timepoint [10] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation
Secondary outcome [11] 0 0
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning
Timepoint [11] 0 0
Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Histologically confirmed stage III (unresectable) or stage IV melanoma

- Treatment naïve patients

- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per
RECIST 1.1 criteria

- Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastases or leptomeningeal metastases

- Ocular melanoma

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of treatment

- Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated
antigen-4 (anti-CTLA-4) antibody

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
Accrual to date
Final
1296
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0017 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0031 - Coffs Harbour
Recruitment hospital [3] 0 0
Local Institution - 0028 - Gateshead
Recruitment hospital [4] 0 0
Local Institution - 0023 - Macquarie University
Recruitment hospital [5] 0 0
Local Institution - 0138 - North Sydney
Recruitment hospital [6] 0 0
Local Institution - 0019 - Brisbane
Recruitment hospital [7] 0 0
Local Institution - 0022 - Southport
Recruitment hospital [8] 0 0
Local Institution - 0018 - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - 0020 - Adelaide
Recruitment hospital [10] 0 0
Local Institution - 0025 - Kurralta Park
Recruitment hospital [11] 0 0
Local Institution - 0024 - Box Hill
Recruitment hospital [12] 0 0
Local Institution - 0016 - Heidelberg
Recruitment hospital [13] 0 0
Local Institution - 0026 - Melbourne
Recruitment hospital [14] 0 0
Local Institution - 0021 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2290 - Gateshead
Recruitment postcode(s) [4] 0 0
2109 - Macquarie University
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
4120 - Brisbane
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3000 - Melbourne
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Maine
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Maryland
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Massachusetts
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Michigan
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Oregon
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Bruxelles
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Edegem
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St. Petersburg
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Spain
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Badalona-Barcelona
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Madrid
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Malaga
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Pamplona
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Gothenberg
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Stockholm
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Zuerich
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Dumfries & Galloway
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Greater London
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with
Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab
alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01844505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01844505